Cincinnati—University of Cincinnati (UC) oncologists are involved in one of the largest international cancer vaccine clinical trials to date aimed at reducing recurrence and improving life expectancy among early-stage lung cancer survivors.

Led locally by Apurva Mehta, MD, the phase-3 trial is expected to enroll a total of 2,300 patients through 100 centers in the United States and 400 globally. Mehta is looking for about five local patients who have stage IB through stage IIIA non small-cell lung cancer to participate in the study.

This vaccine trial, sponsored internationally by GlaxoSmithKline, targets a protein called MAGE-A3, which is expressed in 35 percent of all lung cancers and thought to play a role in cancer recurrence.

Studies have shown a possible link between MAGE-A3 expression and shorter survival in cancer patients. Scientists hope that by administering a vaccine, they can train the immune system to recognize and kill residual cancer cells that represent an increased risk for future disease.

Mehta says surgery is the gold standard for early stage non-small cell lung cancer. However, the five-year recurrence rate is 30 to 60 percent.

“Chemotherapy given after surgery decreases the recurrence by 5 to 15 percent. Clearly more needs to be done to prevent the cancer from recurring,” he explains. “This trial employs the help of the patient’s own immune system to ‘mop off’ the microscopic cancer cells that remain in the body despite surgery and chemotherapy and ultimately cause recurrence.”

The UC Barrett Cancer Center at University Hospital is one of two clinical testing sites currently enrolling patients for the trial in Ohio and the only one in Greater Cincinnati.

Study participants will be screened to determine if their tumors produce MAGE-A3 proteins. After the lung tumor has been completely removed, patients will be randomized into one of two treatment arms to receive either the investigational vaccine or a placebo.

To create the vaccine, antigens known to be present on the tumor cells are combined with other immunotherapeutic agents designed to stimulate the body to produce antibodies and disease-fighting T-cells, which will then target tumor cells expressing MAGE-A3 protein.

The hope is that this immune system boost will help prevent future cancer recurrences throughout the body, not just in the lungs. Because the MAGE-A3 protein is tumor-specific, the immune system—stimulated by the vaccine injection—should destroy the cancerous cells and spare the patient’s normal cells.

“Cancer is produced by your own body, so the immune system does not recognize the cancer cells like it would recognize germs or viruses,” explains Mehta. “The idea is that the vaccine will re-train the immune system to recognize these residual cancerous cells as bad so they don’t slip by the body’s natural defenses.”

During the active treatment phase of the trial, patients will receive up to 13 injections of the investigational vaccine. The first five will take place every three weeks, with the remaining eight given at three-month intervals. Disease recurrence will be monitored through periodic physical examinations as well as blood and imaging tests for five years after active treatment ends.

Mehta stresses there is no guarantee that the new therapy will be effective, but every patient will get the standard of care treatment regardless.

“Even if the new drug therapy doesn’t succeed in improving this patient’s life, it will add to our overall knowledge about the disease and help improve cancer therapies of the future,” he adds. “Patients are monitored very closely, so if there is a recurrence, it will probably be detected faster and earlier when on trial.”

According to the National Cancer Institute, non small-cell lung cancers account for 85 percent of all diagnosed lung cancers, representing 1.2 million new cases worldwide each year.

Early-stage lung cancer is typically asymptomatic, but a cough that won’t go away, shortness of breath or expectorating blood should serve as warning signs that something may be wrong.

“There is no standard screening tool for lung cancer, so the best thing people can do for themselves is stop smoking or never smoke at all,” adds Mehta.

For more information on lung cancer clinical trials, call (513) 558-4445. Mehta has no financial interests in GlaxoSmithKline, sponsor of the study.

The Barrett Cancer Center is part of a joint cancer program involving the UC College of Medicine, Cincinnati Children’s Hospital Medical Center and University Hospital. The collaborative initiative brings together interdisciplinary research teams of caring scientists and health professionals to research and develop new cures, while providing a continuum of care for children, adults and families with cancer.